BenzylPenicillin Injection BP 1.2 MIU Technical Specification:
Product Name: | BenzylPenicillin Injection BP 1.2MIU |
Brand Name: | Generics |
Strength: | 1 MIU (600mg) (10,00,000 IU), 1.2MIU (900mg) (12,00,000 IU), 5 MIU (3000mg) (50,00,000 IU), 0.8 MIU (8,00,000 IU) |
Dosage Form: | Dry Powder for Injection (Sterile) |
Packing: | 1 Vial + WFI in a Tray |
Route of Administration: | For I.M./I.V. use only |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | β-lactam Antibiotic, Anti-bacterial & Penicillin. |
Indication: | Benzylpenicillin is indicated for most wound infections, and pyogenic infections of the body parts. |
Storage: | Store Below 25°C. Protect from light. Do not freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Benzyl Penicillin Injection BP 1.2 MIU
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Benzyl Penicillin for Injection BP 1.2 MIU
Each vial contains:
Benzyl Penicillin Sodium BP
(as sodium) …………………….1,200,000 Units
Sterilized Water for Injection BP…….10ml
THERAPEUTIC INDICATION:
Benzylpenicillin is indicated for most wound infections, pyogenic infections of the skin, soft tissue infections, and infections of the nose, throat, nasal sinuses, respiratory tract, and middle ear, etc.
DIRECTION OF USE:
For I.M./I.V. use only.
The prepared solution should be used immediately.
For dosage, administration and detailed directions for use see the package insert.
CAUTION & Warning:
CAUTION: Do not use the injection if the contents are not clear or contain visible particulate matter after reconstitution.
Not to be Infuse directly: Dilute the preparation with compatible Intravenous solution prior to administration.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Any unused portion must be discarded properly.
WARNING: To be sold by the retailer on the prescription of a registered medical practitioner only.
If any particle is visible in the vial after dissolving the contents, please do not use it & return for a replacement.
STORAGE & DOSAGE:
Storage: Store Below 25°C.
Protect from light.
Do not freeze.
Keep the medicine out of reach of children.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
(A) Benzyl Penicillin for Injection BP 1 MIU
(B) Benzyl Penicillin for Injection BP 1.2 MIU
(C) Benzyl Penicillin for Injection BP 5 MIU
(D) Benzyl Penicillin for Injection BP 0.8 MIU
(B) Benzyl Penicillin for Injection BP 1.2 MIU
(C) Benzyl Penicillin for Injection BP 5 MIU
(D) Benzyl Penicillin for Injection BP 0.8 MIU
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Benzyl Penicillin for Injection BP 1 MIU
a) Each vial contains:
Benzyl Penicillin Sodium BP
Equivalent to Benzyl Penicillin…………………….1,000,000 Units
b) Sterilised Water for Injection BP…….10ml
2. Benzyl Penicillin for Injection BP 1.2 MIU
a) Each vial contains:
Benzylpenicillin Sodium BP
Equivalent to Benzyl Penicillin …………………….1,200,000 Units
b) Sterilised Water for Injection BP…….10ml
3. Benzyl Penicillin for Injection BP 5 MIU
a) Each vial contains:
Benzylpenicillin Sodium BP
Equivalent to Benzyl Penicillin …………………….5,000,000 Units
b) Sterilised Water for Injection BP…….10ml
4. Benzyl Penicillin for Injection BP 0.8 MIU
a) Each vial contains:
Benzylpenicillin Sodium BP
Equivalent to Benzyl Penicillin …………………….8,00,000 Units
b) Sterilised Water for Injection BP…….10ml
a) Each vial contains:
Benzyl Penicillin Sodium BP
Equivalent to Benzyl Penicillin…………………….1,000,000 Units
b) Sterilised Water for Injection BP…….10ml
2. Benzyl Penicillin for Injection BP 1.2 MIU
a) Each vial contains:
Benzylpenicillin Sodium BP
Equivalent to Benzyl Penicillin …………………….1,200,000 Units
b) Sterilised Water for Injection BP…….10ml
3. Benzyl Penicillin for Injection BP 5 MIU
a) Each vial contains:
Benzylpenicillin Sodium BP
Equivalent to Benzyl Penicillin …………………….5,000,000 Units
b) Sterilised Water for Injection BP…….10ml
4. Benzyl Penicillin for Injection BP 0.8 MIU
a) Each vial contains:
Benzylpenicillin Sodium BP
Equivalent to Benzyl Penicillin …………………….8,00,000 Units
b) Sterilised Water for Injection BP…….10ml
THERAPEUTIC INDICATIONS:
Benzylpenicillin is indicated for most wound infections, pyogenic infections of the skin, soft tissue infections and infections of the nose, throat, nasal sinuses, respiratory tract and middle ear, etc.
DIRECTION OF USE:
For I.M./I.V. use only.
The prepared solution should be used immediately.
For dosage, administration and detailed direction for use see pack insert.
The prepared solution should be used immediately.
For dosage, administration and detailed direction for use see pack insert.
CAUTION & WARNING:
CAUTION: Do not use the injection if the contents are not clear or contains visible particulate matter after reconstitution.
Not to be Infuse directly: Dilute the preparation with compatible Intravenous solution prior to administration.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Any unused portion must be Discarded properly.
WARNING: To be sold by the retail on the prescription of a registered medical practitioner only.
If any particle is visible in the vial after dissolving the contents, please do not use & return for replacement.
Not to be Infuse directly: Dilute the preparation with compatible Intravenous solution prior to administration.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Any unused portion must be Discarded properly.
WARNING: To be sold by the retail on the prescription of a registered medical practitioner only.
If any particle is visible in the vial after dissolving the contents, please do not use & return for replacement.
STORAGE & DOSAGE:
Storage: Store Below 25°C.
Protect from light.
Do not freeze.
Keep medicine out of reach of children.
Dosage: As directed by Physician.
Protect from light.
Do not freeze.
Keep medicine out of reach of children.
Dosage: As directed by Physician.